TACE Plus HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Refractory to Standard Treatment Regimens

NCT06071052 | Completed Phase 2 DMC

• 1 other identifier: 2022519
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Liver metastasis is the main reason that affects the survival rates of patients with colorectal cancer (CRLM), and is also the main cause of death of those patients. Especially after the failure of first-line or second-line system treatment, the prognosis of those patients is extremely poor, with the median OS of only 3.5 months. Even in combination with molecular targeted drugs such as cetuximab or bevacizumab, the median tumor-free survival period is only 4.8-6.8 months, and OS is only 11-15 months. When they have disease progression, treatment is currently a difficult clinical problem. Regofinib is a new targeted drug for the third-line treatment of advanced colorectal cancer in recent years. However, in the prospective multicenter clinical study, compared with the placebo group, the extended OS is only 1.4 months, which is not so satisfactory. How to improve the survival of these advanced patients with drug resistance is an important clinical problem to be solved urgently. Minimally invasive local treatment may be a promising way to solve this problem. Transcatheter arterial chemoembolization (TACE) and hepatic artery infusion chemotherapy (HAIC) are currently the most widely used methods in clinical practice. In theory, TACE combined with HAIC can control small metastasis and embolic residual lesions. The combination of TACE and HAIC can improve the curative effect. Whether the combination of TACE, HAIC and Regofinib can be expected to achieve the effect of 1+1+1\>3 in CRLM patients who have failed the previous second-line chemotherapy remains unknown. Therefore, the purpose of this study is to explore the safety and clinical efficacy of irinotecan-loaded drug-eluting beads-TACE (DEBIRI-TACE) combined with HAIC and Regofinib in the treatment of patients with CRLM who failed standard treatment regimens.

Conditions

Liver Metastasis Colon Cancer

Keywords

Liver Metastasis Colon Cancer; Transcatheter arterial chemoembolization; perfusion chemotherapy; Regofinib

Outcome Measures

Primary Outcomes (2)

• Objective response rate, ORR

  The objective response rate is defined as the proportion of patients in complete and partial remission, and the treatment response is based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST)

  through study completion, an average of 1 year

• Time to progression, TTP

  It is defined as the time from randomization to disease progression throughout the entire experiment. Patients who withdraw or are lost will be treated as deleted, and their known last survival date will be used as the final survival time. Patients who did not make progress at the end of the study will be treated as deleted, with the known last date of survival as the final survival time. Death will also be treated as deletion, with the time of death as the final survival time.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Overall Survival, OS

  through study completion, an average of 1 year

• Negative conversion rate of the tumor index

  through study completion, an average of 1 year

• Transformation and resection rate and ablation rate of liver metastases

  through study completion, an average of 1 year

• Safety evaluation

  through study completion, an average of 1 year

Study Arms (1)

TACE and HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer

EXPERIMENTAL

liver metastasis of colorectal cancer patients who fail the second line, receive transhepatic artery irinotecan vehicle microsphere embolization and perfusion chemotherapy combined with regorafenib

Combination Product: TACE and HAIC Combined With Regorafenib

Interventions

TACE and HAIC Combined With Regorafenib COMBINATION_PRODUCT

TACE and HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer who failed the second line treatment regimens

TACE and HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 years old, gender unlimited;
• Patients with liver metastasis of colorectal cancer by pathological histology or clinical diagnosis (refer to the Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastasis of Colorectal Cancer, 2016 Edition), those who were mainly exposed to liver metastasis with large tumor load and suffered from no clear extrahepatic metastasis;
• Patients with a liver area tumor no more than 5 tumor nodules, and a nodule size no more than10cm;
• Patients subject to the failure of previous chemotherapy regimen containing irinotecan or oxaliplatin after at least six cycles of systemic chemotherapy; they cannot undergo surgery or refuse surgery;
• Patients with liver tumor who did not receive interventional treatment (TACE, ablation, iodine particle treatment, etc.) within one year;
• Patients with an expected survival period longer than 3 months;
• Patients with favorable liver function (7 points for Child-Pugh A or B);
• Patients with a physical fitness ECOG no more than one point;
• Patients who understood and signed the Informed Consent Form.

You may not qualify if:

• Patients with distant metastases except the liver;
• Patients subject to the treatment of TACE, ablation or iodine particles within one year;
• Patients with obvious artero / venous fistula and cancer plugs in the main portal vein;
• Patients who had suffered from or were currently developing other malignant tumors (except for the cured basal or squamous cell skin carcinoma or cervical carcinoma in situ);
• Patients whose white blood cells were less than 3,000 cell / mm3, or platelet count less than 50,000 / mm3;
• Patients subject to renal insufficiency (creatinine\> 2 mg/L);
• Patients whose AST and / or ALT was / were more than 5 times the upper limit of normal;
• Patients with poor coagulation function, an INR larger than 1.5, or currently subject to anticoagulant therapy or known hemorrhagic disease;
• Patients with a history of major disease with heart, kidney, bone marrow, or lung, and central nervous system involvement;
• Patients requiring antibiotic treatment due to recent infections;
• Patients subject to comorbidities or social environment that could prevent them from following the study plan or even endanger their safety.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

the first affiliated hospital, Sun-Yat sen university

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

regorafenib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of the department of interventional oncology

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 6, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)